Status:
TERMINATED
Phase 3 Study of Nimotuzumab and Irinotecan as Second Line With Advanced or Recurrect Gastric and Gastroesophageal Junction Cancer
Lead Sponsor:
Kuhnil Pharmaceutical Co., Ltd.
Collaborating Sponsors:
Daiichi Sankyo Co., Ltd.
Conditions:
Gastric Cancer
Gastroesophageal Junction Cancer
Eligibility:
All Genders
20+ years
Phase:
PHASE3
Brief Summary
This study will evaluate overall survival of nimotuzumab in combination with irinotecan compared to irinotecan alone in subjects with EGFR overexpressed advanced gastric or gastroesophageal junction c...
Detailed Description
This randomized, open-label, Japan, Korea and Taiwan collaborative, phase 3 study will evaluate overall survival of nimotuzumab in combination with irinotecan compared to irinotecan alone in subjects ...
Eligibility Criteria
Inclusion
- Advanced or recurrent subjects with gastric or gastroesophageal junction adenocarcinoma.
- Subjects who experienced disease progression during first line or within 6 months after the last dose of first line therapy. The first line regimen must have contained a 5-fluorouracil based agent and platinum agent.
- Subjects with EGFR overexpression (2+ or 3+ in IHC)
Exclusion
- Subjects who have received irinotecan
- Subjects who have received EGFR-directed therapy
- Other active malignancy within the last 5 years
Key Trial Info
Start Date :
May 13 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 19 2018
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT01813253
Start Date
May 13 2013
End Date
February 19 2018
Last Update
March 26 2018
Active Locations (37)
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1
National Cancer Center Hospital East
Kashiwa, Chiba, Japan, 277-0882
2
Aichi, Japan
3
Akita, Japan
4
Aomori, Japan